A positive finding of toxicity in the test animals in a poorly controlled study provides a reasonable lower bound on the true toxicity of the substance. The agency must be tree to conclude that the results from such a study, while admittedly imprecise as to incidence or severity of the untoward effect, cannot be overlooked in arriving at a decision concerning the toxic potential of the product."
It would be very easy to give you another 50 pages of the horrors of original aspartame studies. You simply can't take a deadly chemical poison and have it show safety. It can't be done. Searle got caught constantly.
For instance in the aspartame (DKP) 115 week rat study the written observations of the pathology report was changed by the supervising pathologist, Dr. Rudolph Stejskal even though he was not physically present during the autopsies and could not have verified the observations of the pathology who did perform the autopsies. The pathologist who did perform some of the autopsies had no formal training for such procedures. (Gross l985, page S10837 of Congressional Record l985b).
You could go from study to study and show the fraud. For instance in the aspartame 46 week hamster study, blood samples reported in the submission to FDA as 26 week values (for certain specified animals) were found by investigators as being, in fact, values for different animals which were bled at the 38th week. Many of the animals for which these values were reported (to the FDA) were dead at the 38th week." (Gross 1985, page S10838 of congressional record l985b).
There were "clerical or arithmetic errors which resulted in reports of few tumors." (Schmidt 1976c, page 27 of US Senate l976b). G. D. Searle "delayed the reporting of alarming findings." (Schmidt 1976c, page 27 of US Senate 1976b).
Dr. Adrian Gross, FDA toxicologist who was on site really summed it up when he said:
"They ( G.. D. Searle) lied and they didn't submit the real nature of their observations because had they done that it is more than likely that a great number of these studies would have been rejected simply for adequacy. What Searle did, they took great pains to camouflage these shortcomings of the study. As I say filter and just present to the FDA what they wished the FDA to know and they did other terrible things for instance animals would develop tumors while they were under study. Well they would remove these tumors from the animals." Wilson l985
FDA lead investigator and Task Force Team Leader, Phillip Brodsky described the 1975 FDA Task Force members as some of the most experienced drug investigators. He went on to state that he had never seen anything as bas as G. D. Searle's studies (Graves 1984, page S5499 of Congressional Record l985a).
Dr. Marvin Legator, professor and director of environmental toxicology at the University of Texas and the pioneer of mutagenicity testing at the FDA from 1962 to 1972 was asked by Common Cause Magazine to review the FDA investigation results of G. D. Searle's tests (Graves 1984, page S5498 of Congressional Record 1985a):
"All tests were scientifically irresponsible and disgraceful. I'm just shocked that that kind of sloppy work would even be sent to FDA, and that the FDA administrators accepted it. There is no reason why these tests couldn't have been carried out correctly. It's not that we are talking about some great scientific breakthrough in methodology."
Senator Edward Kennedy at the April 8, 1976 hearings before the Senate Subcommittee on Labor and Public Welfare stated (Kennedy l976): "The extensive nature of the almost unbelievable range of abuses discovered by the FDA on several major Searle products is profoundly disturbing."
Senator Ige, this is what we know: no doubt a lot was hidden. In fact, Dr. Adrian Gross said the deliberate misconduct and lies invalidated all their experiments for these reasons:
1. Many of the problems with the studies included horrendous experimental designs, questions regarding dosage given, loss of animal tissue and data, etc.. which invalidates entire experiments and causes what they claim to be 4 million observations and calculations per study (average) to become irrelevant.
2. Only the key aspartame studies were looked at. It is almost a certainty that the non-key aspartame studies were equally flawed. Therefore, this would invalidate the "hundreds of millions" of observations and calculations made during these studies.
3. The difference between a study showing no statistical difference and a significant statistical difference is often only a few observations or calculations. Therefore, had the myriad of other serious experimental errors not occurred, the observation and calculation mistakes in each experiment investigated would, by themselves, invalidate most of the key studies.
4. It is highly unlikely that the FDA Investigative teams found all of the problems with G. D. Searle's studies. G. D. Searle seemed so intent on covering up their misconduct, that it is quite likely that they were able to hide many of the problems from the FDA.
So you see, Senator Ige, no matter what the aspartame industry says, about aspartame being the most tested additive in history and showing safety, the public record shows aspartame never showed safety at all. What it did show was massive fraud, and they got out of it by buying the U.S. Prosecutors who were never investigated for not doing their job and instead going to work for the defense team.
So FDA revoked the petition for approval. Here is that report. http://www.mpwhi.com/fda_petition1.doc
Before the FDA Commissioner, Dr. Jere Goyan could sign this into law, the next day Searle filed suit. Don Rumsfeld was CEO of Searle, hired to get them out of trouble. He said he would call in his markers and get aspartame on the market anyway. What were those markers?
President Reagan had told Rumsfeld he would nominate him for Vice President but instead nominated Bush. Rumsfeld said Reagan owed him a favor and Reagan paid it. Rumsfeld was on Reagan's transition team and the day after President Reagan took office he appointed Dr. Arthur Hull Hayes as FDA Commissioner to over-rule the Board of Inquiry. Knowing it would take 30 days to get him there he wrote an executive order making the FDA powerless to do anything about aspartame.
This executive order is suppose to be a matter of public record but today has been stricken. Someone from the Reagan Transition Team called FDA Commissioner, Dr. Jere Goyan at 3:00 AM in the morning and fired him. Here is the actual letter from Dr. Goyan's wife who at the time was with him when he received the call. Notice she mentions that executive order. www.mpwhi.com/letter_about_goyan.pdf
Dr. Goyan died just a few months ago.
Back during those days the FDA was the hero. A former Searle employee once wrote an article titled: "What Happened To the Old FDA?" Her question was answered by the Philadelphia Inquirer on 11/22/87: The New FDA: Good Medicine for Drug Firms: http://www.mpwhi.com/the_new_fda.htm This is when as the article points out the FDA stopped operating in an adversary role and became a friend of the drug industry. This is the FDA under Dr. Arthur Hull Hayes who was put there specifically to put one of the most deadly drugs on the market to mass poison the American Public and today over 100 countries of the world. Rumors fly on what they had on Hayes to get him to do this deadly deed. When he over-ruled the Board of Inquiry and put aspartame on the market he has refused to speak to the press ever since.
In l983 the National Soft Drink Association protested that aspartame not be approved in carbonated beverages even mentioning the law that makes it illegal to market a product that is adulterated. They had concluded that aspartame is not safe in carbonated beverages. http://www.mpwhi.com/open_letter_dick_adamson.htm
On July 8, l983 Acing Commissioner of the FDA, Mark Novitch, approved NutraSweet for use in carbonated beverages and carbonated beverage syrup bases, even though levels of aspartame remaining in beverages stored eight weeks at 68 degrees F were between 84% and 89% of the original amount. "Lost" aspartame degrades to DKP (a brain tumor agent), methanol, a severe metabolic poison, aspartic acid, an excitotoxin, and phenylalanine, as an isolate a neurotoxin that lowers the seizure threshold and depletes serotonin triggering psychiatric and behavioral problems. Aspartame interacts with all antidepressants.
I personally called Mark Novitch recently and asked him about what he did. It seems Mr. Novitch, who did this under the direction of Arthur Hull Hayes, had a bad case of amnesia. He said it was so long ago he just couldn't remember anything on the issue. That was certainly a convenient loss of memory. Memory loss is #9 on the FDA list of 92 documented symptoms from aspartame from four types of seizures to coma and death.
Amid allegations of using General Foods jet and other things, Dr. Hayes resigned and went to work for the PR Agency of the manufacturer on a ten year contract for $1000.00 a day. What does an FDA Commissioner do for a PR agency? Send postcards home from Bermuda. One article said he was there about 15 days.
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